Good Clinical Practice (GCP)

The requirement to conduct all clinical trials in accordance with the internationally recognised principles of GCP helps to ensure that all UK trials are conducted to the appropriate high standard, and that risks to patient volunteers are minimised.

Good Manufacturing Practice (GMP)

The requirement to manufacture investigational medicinal products to GMP standards ensures that trial participants are not exposed to poor quality or badly prepared medicines.

GCP and GMP inspections and enforcement

Inspections by the MHRA to check that the principles and standards of GCP and GMP are being followed ensures overall quality of UK clinical trials and helps identify non-compliance. If non-compliance persists, or inspectors suspect fraud, the regulations provide powers of enforcement.

Protection of incapacitated adults

The Regulations contain provisions for the protection of adults incapable of giving informed consent, for example, those with advanced Alzheimer's disease, who should be able to benefit from research that can improve their condition. However, the decision on whether to consent to, or refuse, participation in a trial will be taken by a 'consultee' who is independent of the research team and should act on the basis of the person's presumed wishes.

Protection of minors

The Regulations provide additional protection for a minor who is being considered for a clinical trial, i.e. a person under the age of 16.

They require, among other provisions, that:

the REC considering the trial must receive advice on the relevant field of paediatric care

a person with parental responsibility or legal representative must give informed consent and may withdraw the young person at any time.

In relation to the minor him/herself:

staff with experience with young people must inform them of the risks and benefits of the trial according to their capacity to understand

the investigator must consider their explicit wish to refuse to participate or to be withdrawn from the trial at any time

the clinical trial must relate directly to an illness from which (s)he suffers or that can only be carried out on minors

the trial must aim to provide some direct benefit for the group of patients involved.

Pharmacovigilance arrangements

For all Clinical Trials of an IMP, systems must be in place for the review of adverse events and processing of serious adverse events, which must be immediately reported to the Sponsor, unless identified in the protocol or investigator's brochure as not requiring immediate reporting.

Investigators and trial sponsors together must record suspected unexpected serious adverse reactions thought to be caused by the trial medicine and report them to the MHRA. Assessors at the MHRA can identify safety signals from these reports indicating when trial participants are at increased risk and the trial should be modified or stopped.

The Directive also requires each of the 25 Member States to enter safety data from trials in their country into a single European pharmacovigilance database, which will be a resource to the UK for early identification of safety signals derived from the clinical trials.